MIDLINE II-Ti M421312cRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815101021867), received between Sep 19, 2019 and Sep 19, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2019Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS COMMUNICATED THAT A REVISION SURGERY WAS TO BE PERFORMED FOR A MIDLINE II IMPLANTATION THAT HAD ORIGINALLY BEEN PERFORMED ON (B)(6) 2016. THE IMPLANTATION INCLUDED A MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE SCREWS AND ADDITIONAL POSTERIOR HARDWARE FROM AN ALTERNATIVE MANUFACTURER. FOLLOW-UP IMAGING NOTED WHAT APPEARED TO BE A REACTION AROUND THE ALTERNATIVE MANUFACTURER'S TITANIUM PEDICLE SCREWS AND TO A LESSER EXTENT AROUND THE MIDLINE II-TI AND STALIF MIDLINE SCREWS. THE REVISION SURGERY WAS CONFIRMED AND TOOK PLACE ON (B)(6) 2017 TO REMOVE ALL TITANIUM DEVICES AND REPLACING WITH PEEK ONLY AND ALLOGRAFT. THE INITIAL CONTACT FORM WAS RECEIVED ON 10/10/17 CONFIRMING THAT THE REACTION WAS POTENTIALLY CAUSED BY AN ALLERGIC REACTION TO THE TITANIUM. THIS HAS NOT YET BEEN CONFIRMED BY AN ALLERGIST. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THE COMPLETED REVISION SURGERY INDICATING THE POSSIBILITY OF ALLERGIC REACTION TO TITANIUM. THIS REPORT IS 4 OF 4 FOR 1 MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE ABO SCREWS.

  Patient problems: Local Reaction

  MAUDE report 9088354 ↗
• InjurySep 19, 2019Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS COMMUNICATED THAT A REVISION SURGERY WAS TO BE PERFORMED FOR A MIDLINE II IMPLANTATION THAT HAD ORIGINALLY BEEN PERFORMED ON (B)(6) 2016. THE IMPLANTATION INCLUDED A MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE SCREWS AND ADDITIONAL POSTERIOR HARDWARE FROM AN ALTERNATIVE MANUFACTURER. FOLLOW-UP IMAGING NOTED WHAT APPEARED TO BE A REACTION AROUND THE ALTERNATIVE MANUFACTURER'S TITANIUM PEDICLE SCREWS AND TO A LESSER EXTENT AROUND THE MIDLINE II-TI AND STALIF MIDLINE SCREWS. THE REVISION SURGERY WAS CONFIRMED AND TOOK PLACE ON (B)(6) 2017 TO REMOVE ALL TITANIUM DEVICES AND REPLACING WITH PEEK ONLY AND ALLOGRAFT. THE INITIAL CONTACT FORM WAS RECEIVED ON (B)(6) 2017 CONFIRMING THAT THE REACTION WAS POTENTIALLY CAUSED BY AN ALLERGIC REACTION TO THE TITANIUM. THIS HAS NOT YET BEEN CONFIRMED BY AN ALLERGIST. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THE COMPLETED REVISION SURGERY INDICATING THE POSSIBILITY OF ALLERGIC REACTION TO TITANIUM. THIS REPORT IS 3 OF 4 FOR 1 MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE ABO SCREWS.

  Patient problems: Local Reaction

  MAUDE report 9088351 ↗
• InjurySep 19, 2019Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS COMMUNICATED THAT A REVISION SURGERY WAS TO BE PERFORMED FOR A MIDLINE II IMPLANTATION THAT HAD ORIGINALLY BEEN PERFORMED ON (B)(6) 2016. THE IMPLANTATION INCLUDED A MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE SCREWS AND ADDITIONAL POSTERIOR HARDWARE FROM AN ALTERNATIVE MANUFACTURER. FOLLOW-UP IMAGING NOTED WHAT APPEARED TO BE A REACTION AROUND THE ALTERNATIVE MANUFACTURER'S TITANIUM PEDICLE SCREWS AND TO A LESSER EXTENT AROUND THE MIDLINE II-TI AND STALIF MIDLINE SCREWS. THE REVISION SURGERY WAS CONFIRMED AND TOOK PLACE ON (B)(6) 2017 TO REMOVE ALL TITANIUM DEVICES AND REPLACING WITH PEEK ONLY AND ALLOGRAFT. THE INITIAL CONTACT FORM WAS RECEIVED ON 10/10/2017 CONFIRMING THAT THE REACTION WAS POTENTIALLY CAUSED BY AN ALLERGIC REACTION TO THE TITANIUM. THIS HAS NOT YET BEEN CONFIRMED BY AN ALLERGIST. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THE COMPLETED REVISION SURGERY INDICATING THE POSSIBILITY OF ALLERGIC REACTION TO TITANIUM. THIS REPORT IS 2 OF 4 FOR 1 MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE ABO SCREWS.

  Patient problems: Local Reaction

  MAUDE report 9088350 ↗
• InjurySep 19, 2019Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS COMMUNICATED THAT A REVISION SURGERY WAS TO BE PERFORMED FOR A MIDLINE II IMPLANTATION THAT HAD ORIGINALLY BEEN PERFORMED ON (B)(6) 2016. THE IMPLANTATION INCLUDED A MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE SCREWS AND ADDITIONAL POSTERIOR HARDWARE FROM AN ALTERNATIVE MANUFACTURER. FOLLOW-UP IMAGING NOTED WHAT APPEARED TO BE A REACTION AROUND THE ALTERNATIVE MANUFACTURER'S TITANIUM PEDICLE SCREWS AND TO A LESSER EXTENT AROUND THE MIDLINE II-TI AND STALIF MIDLINE SCREWS. THE REVISION SURGERY WAS CONFIRMED AND TOOK PLACE ON (B)(6) 2017 TO REMOVE ALL TITANIUM DEVICES AND REPLACING WITH PEEK ONLY AND ALLOGRAFT. THE INITIAL CONTACT FORM WAS RECEIVED ON (B)(6) 2017 CONFIRMING THAT THE REACTION WAS POTENTIALLY CAUSED BY AN ALLERGIC REACTION TO THE TITANIUM. THIS HAS NOT YET BEEN CONFIRMED BY AN ALLERGIST. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED TO BE DOING WELL. THIS REPORT IS BEING SUBMITTED WITHIN 30 DAYS OF THE COMPLETED REVISION SURGERY INDICATING THE POSSIBILITY OF ALLERGIC REACTION TO TITANIUM. THIS REPORT IS 1 OF 4 FOR 1 MIDLINE II-TI CAGE AND 3 X STALIF MIDLINE ABO SCREWS.

  Patient problems: Local Reaction

  MAUDE report 9088312 ↗